Design and rationale for REVERXaL: A real-world study of patients with factor Xa inhibitor-associated major bleeds.

Autor: Alikhan R; University Hospital of Wales and Cardiff University School of Medicine, Cardiff, Wales, United Kingdom. Electronic address: Raza.Alikhan@wales.nhs.uk., Nour M; University of California, Los Angeles, California, United States., Yasaka M; Fukuoka Neurosurgical Hospital, Fukuoka, Japan., Ofori-Asenso R; AstraZeneca, Cambridge, United Kingdom., Axelsson-Chéramy S; AstraZeneca, Gothenburg, Sweden., Chen H; AstraZeneca, Wilmington, Delaware, United States., Seghal V; University College London Hospital, London, United Kingdom., Yokobori S; Nippon Medical School, Tokyo, Japan., Koch B; AstraZeneca, Wilmington, Delaware, United States., Tiede A; Hannover Medical School, Hannover, Germany., Cash BD; University of Texas Health Science Center at Houston, Houston, Texas, United States., Maegele M; Cologne-Merheim Medical Center, Cologne, Germany., Singer AJ; Stony Brook University, New York, New York, United States.
Jazyk: angličtina
Zdroj: Thrombosis research [Thromb Res] 2024 Aug; Vol. 240, pp. 109046. Date of Electronic Publication: 2024 Jun 05.
DOI: 10.1016/j.thromres.2024.109046
Abstrakt: Background: The prevalence of anticoagulation treatment is increasing as an aging global population faces a high burden of cardiovascular comorbidities. Direct oral anticoagulants, including factor Xa inhibitors (FXai), are replacing vitamin K antagonists as the most commonly prescribed treatment for reducing risk of thrombotic events. While the risk of FXai-associated spontaneous bleeds is established, less is understood about their management and the effect of treatment on clinical and patient-reported outcomes. The primary objectives of the REVERXaL study are to describe patient characteristics, health care interventions during the acute-care phase, in-hospital outcomes, and associations between timing of reversal/replacement agent administration and in-hospital outcomes. Secondary/exploratory objectives focus on clinical assessments and patient-reported outcome measures (PROMs) at 30 and 90 days.
Methods: REVERXaL is a multinational, observational study of hospitalized patients with FXai-associated major bleeds in Germany, Japan, the United Kingdom, and the United States. The study includes 2 cohorts of approximately 2000 patients each. Cohort A is a historic cohort for whom medical chart data will be collected from hospitalization to discharge for patients admitted for major bleeds during FXai use within 2 years prior to enrollment of Cohort B. Cohort B will prospectively enroll patients administered any reversal/replacement agent during hospitalization to manage FXai-associated major bleeds and will include the collection of clinical outcomes and PROMs data over 3 months.
Conclusions: REVERXaL will generate insights on patient characteristics, treatment approaches, and associated outcomes in patients hospitalized with FXai-associated major bleeds. These data may inform clinical practice and streamline treatment pathways in this population.
Registration: URL: https://www.
Clinicaltrials: gov; unique identifier: NCT06147830.
Competing Interests: Declaration of competing interest MN and SY have no conflicts of interest to disclose. RA has received fees for consulting work from AstraZeneca, Alexion, Bristol Myers Squibb, Pfizer, Bayer, and Daiichi. RO-A, SA-C, HC, and BK are employees of AstraZeneca. MY has received lecture, advisory, and travel fees from AstraZeneca, Bristol Myers Squibb, Nippon Boehringer Ingelheim, Bayer, Daiichi Sankyo, and CSL Behring; and scholarship funds or nonrestricted grants from Nippon Boehringer Ingelheim. VS has served as a consultant for Apollo Endosurgery, Pentax, Medtronic, Pharmacosmos, Microtech, and AstraZeneca; has served on advisory boards for Pharmacosmos and Microtech; and has received educational grants from Apollo Endosurgery, Pentax, and Medtronic. AT has received consulting fees from Bayer, Biomarin, Biotest, Chugai, Roche, Takeda, CSL Behring, Novo Nordisk, Octapharma, Pfizer, and Sobi; has received payment or honoraria for lectures, presentations, speakers bureaus, or educational events from Bayer, Biomarin, Biotest, Chugai, Roche, Takeda, CSL Behring, Novo Nordisk, Octapharma, Pfizer, and Sobi; and has received support for attending meetings and/or travel from Bayer, Biomarin, Biotest, Chugai, Roche, Takeda, CSL Behring, Novo Nordisk, Octapharma, Pfizer, and Sobi. BDC has served as a consultant for AstraZeneca. MM has received lecture honoraria, payment for participation in expert and advisory panels, and financial support for scientific meeting participation from AstraZeneca, Baxter, Bayer, Biotest, CSL Behring, IL-Werfen/TEM-International, LFB Biomedicaments France, Octapharma, and Portola. AJS has served on an advisory board for Alexion and AstraZeneca; has served on the speakers bureau of Alexion and AstraZeneca; and his institution has received research funding from Alexion.
(Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
Databáze: MEDLINE
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